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FDA 510(k)

VENTREX 125I ANTI-IGE ALLERGY ISOTOPE

K-Number: K820896 · 1982-04-21

ApplicantVentrex Laboratories, Inc.
Decision Date1982-04-21
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VENTREX 125I ANTI-IGE ALLERGY ISOTOPE is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1982-04-21 under 510(k) number K820896. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTREX 125I ANTI-IGE ALLERGY ISOTOPE?

VENTREX 125I ANTI-IGE ALLERGY ISOTOPE is a medical device that received FDA 510(k) clearance on 1982-04-21. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K820896.

When did VENTREX 125I ANTI-IGE ALLERGY ISOTOPE receive FDA 510(k) clearance?

VENTREX 125I ANTI-IGE ALLERGY ISOTOPE received FDA 510(k) clearance on 1982-04-21, under 510(k) number K820896.

Who is the listed applicant for VENTREX 125I ANTI-IGE ALLERGY ISOTOPE?

The FDA 510(k) record lists Ventrex Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTREX 125I ANTI-IGE ALLERGY ISOTOPE?

The FDA product code for VENTREX 125I ANTI-IGE ALLERGY ISOTOPE is DGC.

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Other records listing Ventrex Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KIT

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Related Devices (Code: DGC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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